TRAUMED- arnica root tablet
MediNatura Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Traumed Tablet

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS

For the temporary relief of minor pain due to overexertion, bruises, minor injuries

WARNINGS

If pregnant or breast-feeding, ask a health professional before use. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to Traumed® or any of its ingredients exists.

DOSAGE

Directions: At first sign of symptoms:Adults and children 4 years and older:

1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.

Standard dosage:

Adults and children 4 years and older:

3 tablets per day, taking 1 tablet every 4 to 6 hours.

Allow tablets to dissolve completely in the mouth, do not swallow

ACTIVE INGREDIENTS

Active Ingredients: Each tablet contains: *Arnica montana, radix 6X, 12X, 30X, 200X, 75 mg each.

*Natural ingredients

INACTIVE INGREDIENTS

Inactive Ingredients: Lactose, Magnesium stearate

PURPOSE

Relieves Pain due to:

• Overexertion

• Bruises

• Minor Injury

Traumed Tablet

Add image transcription here...

TRAUMED
arnica root tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62795-2301
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	Leafman
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62795-2301-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2017	03/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/30/2014	03/06/2023

Labeler - MediNatura Inc. (079324099)

Name	Address	ID/FEI	Business Operations
Establishment
MediNatura Inc.		102783016	manufacture(62795-2301)

Revised: 3/2023

Document Id: 79e38136-38c2-49cc-9aff-bf058e39d8d4

Set id: ab31c5d2-8d12-4dbe-be50-362eddd4dd94

Version: 3

Effective Time: 20230306

MediNatura Inc.